U.S. patent application number 09/906376 was filed with the patent office on 2003-01-16 for hemostasis gasket valve.
This patent application is currently assigned to SciMed Life Systems, Inc.. Invention is credited to Houde, Eric, Tansey, William J. JR., Van Diver, Mark H..
Application Number | 20030014015 09/906376 |
Document ID | / |
Family ID | 25422335 |
Filed Date | 2003-01-16 |
United States Patent
Application |
20030014015 |
Kind Code |
A1 |
Tansey, William J. JR. ; et
al. |
January 16, 2003 |
Hemostasis gasket valve
Abstract
An improved vascular introducer sheath having a hemostasis valve
assembly which provides tailored distribution of compressive forces
along one of the top and bottom edges of each slit to avoid
puckering of the slit(s) and to provide balanced performance in
terms of bi-directional sealing effectiveness and device movement
therethrough.
Inventors: |
Tansey, William J. JR.;
(Ballston Spa, NY) ; Van Diver, Mark H.; (Argyle,
NY) ; Houde, Eric; (Saratoga Springs, NY) |
Correspondence
Address: |
Robert E. Atkinson
CROMPTON, SEAGER & TUFTE, LLC
331 Second Avenue South, Suite 895
Minneapolis
MN
55401-2246
US
|
Assignee: |
SciMed Life Systems, Inc.
|
Family ID: |
25422335 |
Appl. No.: |
09/906376 |
Filed: |
July 16, 2001 |
Current U.S.
Class: |
604/167.04 |
Current CPC
Class: |
A61M 39/0606 20130101;
A61M 2039/0633 20130101; A61M 2039/064 20130101 |
Class at
Publication: |
604/167.04 |
International
Class: |
A61M 005/178 |
Claims
What is claimed is:
1. A vascular introducer sheath for use with a vascular access
system, the vascular introducer sheath comprising: a tubular shaft
having a proximal end and a distal end; and a hemostasis valve
assembly connected to the proximal end of the tubular shaft, the
hemostasis valve assembly including a hub, a cap, and a gasket
disposed therebetween, wherein the gasket has one or more slits
each having a top edge and a bottom edge, and wherein the hub and
the cap distribute compressive forces along one of the top and
bottom edges of each slit such that the slits do not pucker.
2. A vascular introducer sheath as in claim 1, wherein the gasket
is curved only along an axis parallel to each slit.
3. A vascular introducer sheath as in claim 1, wherein the gasket
has a single slit and wherein the gasket is curved along an axis
parallel to the single slit to form a semi-cylindrically shaped
gasket.
4. A vascular introducer sheath as in claim 1, wherein the gasket
has a first slit and a second slit, wherein the gasket is curved in
a first direction along an axis parallel to the first slit, wherein
the gasket is curved in a second direction along an axis parallel
to the second slit, and wherein the first direction is different
than the second direction.
5. A vascular introducer sheath as in claim 4, wherein the first
direction is opposite the second direction.
6. A vascular introducer sheath as in claim 5, wherein the first
slit is orthogonal to the second slit to form a saddle shaped
gasket.
7. A vascular introducer sheath for use with a vascular access
system, the vascular introducer sheath comprising: a tubular shaft
having a proximal end and a distal end; and a hemostasis valve
assembly connected to the proximal end of the tubular shaft, the
hemostasis valve assembly including a hub, a cap, and a gasket
disposed therebetween, wherein the gasket has one or more slits,
and wherein the gasket is curved only along an axis parallel to
each slit.
8. A vascular introducer sheath as in claim 7, wherein the gasket
has a single slit and wherein the gasket is curved along an axis
parallel to the single slit to form a semi-cylindrically shaped
gasket.
9. A vascular introducer sheath as in claim 7, wherein the gasket
has a first slit and a second slit, wherein the gasket is curved in
a first direction along an axis parallel to the first slit, wherein
the gasket is curved in a second direction along an axis parallel
to the second slit, and wherein the first direction is different
than the second direction.
10. A vascular introducer sheath as in claim 9, wherein the first
direction is opposite the second direction.
11. A vascular introducer sheath as in claim 10, wherein the first
slit is orthogonal to the second slit to form a saddle shaped
gasket.
12. A vascular introducer sheath for use with a vascular access
system, the vascular introducer sheath comprising: a tubular shaft
having a proximal end and a distal end; and a hemostasis valve
assembly connected to the proximal end of the tubular shaft, the
hemostasis valve assembly including a hub, a cap, and a gasket
disposed therebetween, wherein the gasket has a slit, and wherein
the gasket is curved along a single axis to form a
semi-cylindrically shaped gasket.
13. A vascular introducer sheath as in claim 12, wherein the gasket
is curved along an axis parallel to the slit.
14. A vascular introducer sheath as in claim 12, wherein the gasket
is curved along an axis parallel to the slit and is otherwise not
curved.
15. A vascular introducer sheath as in claim 12, wherein the gasket
has a single slit and wherein the gasket is curved along an axis
parallel to the single slit and is flat along an axis orthogonal to
the single slit.
16. A vascular introducer sheath as in claim 12, wherein the slit
has a bottom edge and a top edge, and wherein compressive forces
are distributed along one of the bottom or top edges to avoid slit
puckering.
17. A vascular introducer sheath as in claim 12, wherein no
compressive forces are distributed perpendicular to the bottom and
top edges.
18. A vascular introducer sheath for use with a vascular access
system, the vascular introducer sheath comprising: a tubular shaft
having a proximal end and a distal end; and a hemostasis valve
assembly connected to the proximal end of the tubular shaft, the
hemostasis valve assembly including a hub, a cap, and a gasket
disposed therebetween, wherein the gasket is curved in a first
direction along an axis, wherein the gasket is curved in a second
direction along an axis, and wherein the first direction is
different from the second direction to form a saddle-shaped
gasket.
19. A vascular introducer sheath as in claim 18, wherein the gasket
has a first slit and a second slit, wherein the gasket is curved in
the first direction along an axis parallel to the first slit, and
wherein the gasket is curved in a second direction along an axis
parallel to the second slit.
20. A hemostasis valve assembly for use with a vascular device, the
hemostasis valve assembly comprising a hub, a cap, and a gasket
disposed therebetween, wherein the gasket has one or more slits
each having a top edge and a bottom edge, and wherein compressive
forces are distributed along one of the top and bottom edges of
each slit such that the one or more slits do not pucker.
21. A hemostasis valve assembly for use with a vascular device, the
hemostasis valve assembly comprising a hub, a cap, and a gasket
disposed therebetween, wherein the gasket has a side with a concave
contour and a convex contour.
22. A hemostasis valve assembly for use with a vascular device, the
hemostasis valve assembly comprising a hub, a cap, and a gasket
disposed therebetween, wherein the gasket has one or more slits
each having a top edge and a bottom edge, and wherein the
hemostasis valve assembly includes means for distributing
compressive forces along one of the top and bottom edges of each
slit such that the one or more slits do not pucker.
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to introducer
sheaths for use in medical procedures requiring vascular access.
More specifically, the present invention relates to hemostasis
gasket valves for use in introducer sheaths and other medical
devices.
BACKGROUND OF THE INVENTION
[0002] Vascular introducer sheaths are used in a wide variety of
vascular procedures and typically include an introducer sheath
having a hemostasis valve which inhibits back-bleeding. As a
general matter, the prior art provides a number of different
hemostasis valve designs which typically vary in terms of the valve
shape, slit geometry, slit position, and other design aspects.
There is an ongoing need to improve such hemostasis valve designs
in terms of providing better hemostasis (i.e., preventing
back-bleeding) in the various modes of operation, minimizing drag
on devices inserted therethrough, providing increased resistance to
pressure and vacuum gradients, providing easy loading of devices,
and maximizing safety.
SUMMARY OF THE INVENTION
[0003] In an exemplary embodiment of the present invention, these
disadvantages are addressed by providing, for example, a vascular
introducer sheath having a hemostasis valve assembly including a
gasket onto which compressive forces are distributed to avoid
puckering of the slit(s) and to provide balanced performance in
terms of bi-directional sealing effectiveness and device movement
therethrough. Specific embodiments are described in more detail
hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] FIG. 1 is a plan view of a vascular access system of the
present invention including an introducer sheath and a dilator;
[0005] FIG. 2A is a cross-sectional side view of a hemostasis valve
assembly of the present invention for use with the introducer
sheath illustrated in FIG. 1, taken along a plane orthogonal to the
slit;
[0006] FIG. 2B is a cross-sectional side view of the hemostasis
valve assembly illustrated in FIG. 2A, taken along a plane parallel
to the slit;
[0007] FIG. 3A is an isometric view of the gasket, shown in a flat
position, used in the hemostasis valve assembly shown in FIGS. 2A
and 2B;
[0008] FIG. 3B is an isometric view of the gasket shown in FIG. 3B,
but shown in a curved position;
[0009] FIG. 4 is an isometric view of the hub used in the
hemostasis valve assembly shown in FIGS. 2A and 2B;
[0010] FIG. 5A is a cross-sectional side view of an alternative
hemostasis valve assembly of the present invention for use with the
introducer sheath illustrated in FIG. 1, taken along a plane
parallel to the first slit and orthogonal to the second slit;
[0011] FIG. 5B is a cross-sectional side view of the hemostasis
valve assembly illustrated in FIG. 5A, taken along a plane
orthogonal to the first slit and parallel to the second slit;
[0012] FIG. 6A is an isometric view of the gasket, shown in a
curved position, used in the hemostasis valve assembly shown in
FIGS. 5A and 5B;
[0013] FIG. 6B is a top view of the gasket shown in FIG. 6A;
and
[0014] FIG. 6C is a side view of the gasket shown in FIG. 6A.
DETAILED DESCRIPTION OF THE INVENTION
[0015] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the invention.
[0016] Refer now to FIG. 1 which illustrates a plan view of a
vascular access system 10 in accordance with the present invention.
Vascular access system 10 includes two primary components, namely
an introducer sheath 12 and a dilator 14. Introducer sheath 12
includes an elongate shaft 16 and a hemostasis valve assembly 60.
The hemostasis valve assembly 60 is connected to the proximal end
of the shaft 16 utilizing conventional techniques. Hemostasis valve
assembly 60 includes a hub, a cap and a gasket disposed
therebetween as will be described in greater detail with reference
to the remaining figures. The hub of the hemostasis assembly 60 may
include a side port 18 for connection to a flush or injection tube
subassembly 20. By way of example, not limitation, the shaft 16 of
the introducer sheath 12 may have a size (outside diameter or
profile) ranging from 4F to 16F or larger, and a length ranging
from 10 cm to 25 cm or longer. The distal tip of the elongate shaft
16 is preferably tapered to facilitate smooth insertion into the
vascular system and smooth transition to the dilator 14.
[0017] Refer now to FIGS. 2A and 2B which illustrate
cross-sectional side views of the hemostasis valve assembly 60 for
use with the introducer sheath 12 illustrated in FIG. 1. As
mentioned previously, the hemostasis valve assembly 60 includes a
hub 22, a cap 24 and a gasket 26 disposed therebetween. For
purposes of simplicity and clarity, the side port 19 of the hub 22
is not illustrated. Similarly, although not illustrated for
purposes of simplicity and clarity, the hub 22 and the end cap 24
include a means for compressive connection therebetween, such as a
snap-fit connection or a threaded connection, both of which are
well-known in the art.
[0018] The hub 22 includes an inner lumen 28 extending
therethrough, and the end cap 24 includes an aperture 30 extending
therethrough. The inner lumen 28 of the hub 22 is in fluid
communication with the aperture 30 of the end cap 24 absent the
gasket 26, which includes one or more slits 46 as will be discussed
in more detail hereinafter. The inner lumen 28 and the aperture 30
accommodate intravascular devices such as catheters, guide wires
and the like therein. The hub 22 and the end cap 24 may have
conventional dimensions and may be formed of conventional materials
using known manufacturing techniques.
[0019] Hub 22 includes a contact surface 32 which is in intimate
contact with the bottom surface 34 of the gasket 26. Similarly, the
end cap 24 includes a contact surface 36 in intimate contact with
the top surface 38 of the gasket 26. The contact surfaces 32, 36
may be smooth or include a ridge 40 to assist in imparting
curvature to the gasket 26 and to grip the gasket 26. The contact
surfaces 32, 36 include both curved portions as seen in FIG. 2A and
flat portions as seen in FIG. 2B. FIGS. 2A and 2B are
cross-sectional views taken at orthogonal angles to each other.
Thus, the curved portions of the contact surfaces 32, 36 are
oriented at a right angle to the flat (non-curved) portions of the
contact surfaces 32, 36. The orientation of the curved and flat
portions of the contact surface 32 of the hub 22 may be readily
appreciated from the isometric view of the hub 22 as shown in FIG.
4.
[0020] As seen in FIG. 2A, the curved portions of the contact
surfaces 32, 36 impart curvature to the gasket 26 about an axis
100, which appears as a point in FIG. 2A. The curvature may be
convex as shown, or concave, depending on the direction of
curvature of the curved portions of the contact surfaces 32, 36. As
seen in FIG. 2B, the flat portions of the contact surfaces 32, 36
hold the gasket flat and parallel to the axis 100, which appears as
a line in FIG. 2B. Preferably, the axis 100 is parallel to the slit
46 as discussed in greater detail hereinafter.
[0021] The slit 46 of the gasket 26 includes a top edge 48 and a
bottom edge 50 as shown in FIG. 2B. By orienting the axis 100
parallel to the slit 46 and by curving the gasket 26 about axis 100
while the remainder thereof remains flat, compressive forces are
distributed along the bottom edge 50 of the slit 46 to avoid
puckering and provide enhanced sealing, with or without devices
inserted therein. Compressive forces may be distributed along the
top edge 48 of the slit 46 to have the same effect by changing the
direction of curvature of the gasket 26 (i.e., by changing from a
convex shape as shown to a concave shape).
[0022] The gasket 26 may be normally flat as shown in FIG. 3A. In
response to compression between the hub 22 and the end cap 24, the
gasket 26 is curved about axis 100 and the gasket 26 assumes a
semi-cylindrical shape as seen in FIG. 3B. The gasket 26 may have a
circular outside shape, but preferably has a shape other than round
such as an oval, a square or a rectangle as shown. The
other-than-round perimeter geometry of the gasket 26 and the
corresponding shapes of the recess of the cap 24 and the top
portion of the hub 22 aid in aligning the slit 46 parallel to the
axis of curvature 100 as defined by the curved portions of the
contact surfaces 32, 36.
[0023] The gasket 26 may be formed of a variety of elastomeric
materials such as PDMS, latex or other suitable material.
Preferably, the gasket 26 has a durometer in the range of 15A-50A.
The gasket 26 thickness may range from approximately 0.045 to 0.075
inches and may have outside dimensions ranging from 0.050 to 0.500
inches. The thickness of the gasket 26 may be uniform or may vary
with a thick portion in the middle and a thin portion around the
periphery thereof. The gasket 26 may be punched out of a sheet of
elastomeric material or molded using conventional techniques. The
slit 46 may be punched through the gasket 26 using a cutter or
other suitable means. Those skilled in the art will recognize that
the dimensions, materials and methods of manufacture may be readily
modified without departing from the scope or spirit of the
invention.
[0024] Refer now to FIGS. 5A and 5B which illustrate
cross-sectional side views of an alternative hemostasis valve
assembly 160 of the present invention for use with the introducer
sheath 12 illustrated in FIG. 1. Except as described herein or
otherwise implicit from the drawings, hemostasis valve assembly 160
is similar in design and use as hemostasis valve assembly 60
described previously.
[0025] The hemostasis valve assembly 160 includes a hub 122, a cap
124 and a gasket 126 disposed therebetween. For purposes of
simplicity and clarity, the side port 19 of the hub 122 is not
illustrated. Similarly, although not illustrated, the hub 122 and
the end cap 124 include a means for compressive connection
therebetween, such as a snap-fit connection or a threaded
connection, both of which are well-known in the art.
[0026] The hub 122 includes an inner lumen 128 extending
therethrough, and the end cap 124 includes an aperture 130
extending therethrough. The inner lumen 128 of the hub 122 is in
fluid communication with the aperture 130 of the end cap 124 absent
the gasket 126, which preferably includes two slits 146A and 146B
oriented at orthogonal angles as discussed in more detail
hereinafter. The inner lumen 128 and the aperture 130 accommodate
intravascular devices such as catheters, guide wires and the like
therein. The hub 122 and the end cap 124 may have conventional
dimensions and may be formed of conventional materials using known
manufacturing techniques.
[0027] Hub 122 includes a contact surface 32 which is in intimate
contact with the bottom surface 134 of the gasket 126. Similarly,
the end cap 124 includes a contact surface 136 in intimate contact
with the top surface 138 of the gasket 126. The contact surfaces
132, 136 may be smooth or include a ridge 140 to assist in
imparting curvature to the gasket 126 and to grip the gasket 126.
The contact surfaces 132, 136 include both convex curved portions
as seen in FIG. 5A and concave curved portions as seen in FIG. 5B.
FIGS. 5A and 5B are cross-sectional views taken at orthogonal
angles to each other. Thus, the convex curved portions of the
contact surfaces 132, 136 are oriented at a right angle to the
concave curved portions of the contact surfaces 132, 136.
[0028] As seen in FIG. 5A, the convex curved portions of the
contact surfaces 132, 136 impart convex curvature to the gasket 126
about an axis 100, which appears as a point in FIG. 5A. As seen in
FIG. 5B, the concave curved portions of the contact surfaces 132,
136 impart concave curvature to the gasket 126 about the axis 200,
which appears as a point in FIG. 5B. Preferably, the first axis 100
is parallel to the first slit 146A, and the second axis 200 is
parallel to the second slit 146B as most clearly shown in FIG. 6A
and discussed in greater detail hereinafter.
[0029] The slits 146A and 146B of the gasket 126 each include a top
edge 148A and 148B and a bottom edge 150A and 150B, respectively,
as shown in FIGS. 5A and 5B. By orienting the first axis 100
parallel to the first slit 146A and the second axis 200 parallel to
the second slit 146B, and by curving the gasket 126 about axis 100
in a first direction and curving the gasket 126 about axis 200 in a
second (opposite) direction, compressive forces are distributed
along the bottom edge 150A of the first slit 146A and the top edge
148B of the second slit 146B, to provide balanced performance in
terms of bi-directional sealing effectiveness and device movement
therethrough. In other words, the gasket 126 provides the same
effective seal and the same reduced drag regardless of the
direction of the pressure gradient or the direction of device
movement therein.
[0030] The gasket 126 may be normally flat, and in response to
compression between the hub 122 and the end cap 124, the gasket 126
is curved about axes 100 and 200 to cause the gasket 26 to assume a
saddle shape as seen in FIG. 6A, having both a concave contour and
a convex contour on the same side. Top and side views of the gasket
126 are illustrated in FIGS. 6B and 6C, respectively. The gasket
126 may have a circular outside shape, but preferably has a shape
other than round such as an oval, a square or a rectangle as shown.
The other-than-round perimeter geometry of the gasket 126 and the
corresponding shapes of the recess of the cap 124 and the top
portion of the hub 122 aid in aligning the slits 146A and 146B
parallel to the axes of curvature 100 and 200 as defined by the
convex and concave curved portions of the contact surfaces 132,
136.
[0031] Those skilled in the art will recognize that the present
invention may be manifested in a variety of forms other than the
specific embodiments described and contemplated herein.
Accordingly, departures in form and detail may be made without
departing from the scope and spirit of the present invention as
described in the appended claims.
* * * * *